A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hands or finger to prevent contamination between patient and examiner.

Device Description

Class 1 Nitrile Patient Examination Glove 80LZA, powder free that meets all the requirements of ASTM Standard D6319-00a53 and FDA requirements.

AI/ML Overview

This document describes the performance data for KOH2101, Powder Free Nitrile Examination Gloves, manufactured by SEAL Polymer Industries Berhad. The device is a Class 1 Nitrile Patient Examination Glove intended for medical purposes to prevent contamination between patients and examiners. The performance data is based on ASTM D6319-00a53 and FDA 1000 ml watertight test.

1. Table of Acceptance Criteria and Reported Device Performance:

TEST	ASTM D6319-00aE3 Acceptance Criteria (AQL=2.5%)	KOH2101 Powder Free Nitrile Exam Gloves Reported Performance (AQL=2.5%)
1. Watertight (1000 ml)	G I	Pass G I
2. Length (mm)
XS	Min 230	240 mm minimum for all sizes
S	Min 230
M	Min 230
L	Min 230
XL	Min 230
3. Palm width (mm)
XS	-	<80 mm
S	80 +/- 10	85 +/- 3 mm
M	95 +/- 10	95 +/- 3 mm
L	111 +/- 10	105 +/- 3 mm
XL	-	111 +/- 3 mm
XXL	-	120 +/- 3 mm
4. Thickness (mm)
Finger	Min 0.05	0.08 minimum
Palm	Min 0.05	0.08 minimum
5. Physical Properties
Before Aging
Tensile Strength (Mpa)	Min 14.0	20.7*
Ultimate Elongation (%)	Min 500	609*
After Aging
Tensile Strength (Mpa)	Min 14.0	22.9*
Ultimate Elongation (%)	Min 400	597*
6. Powder Content	-	Below 2mg / glove

Note: The average numbers for physical properties are obtained from Attachment C, which is not provided in this document.

2. Sample Size Used for the Test Set and Data Provenance:

The document does not explicitly state the specific sample sizes used for each test criterion. However, all tests are performed according to ASTM D6319-00aE3 and FDA 1000 ml watertight test standards, which define the testing methodologies and potentially the sample sizes. The data provenance is Malaysia, as the submitter, SEAL POLYMER INDUSTRIES BERHAD, is located in Perak, Malaysia. The study appears to be a prospective examination of the manufactured gloves to ensure they meet the defined standards.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

Not applicable. The ground truth for glove performance is established by standardized testing protocols (ASTM D6319-00aE3 and FDA 1000 ml watertight test), not by expert consensus in the typical sense of diagnostic imaging or clinical decisions.

4. Adjudication Method for the Test Set:

Not applicable. The performance is determined by objective measurements against predefined criteria in the ASTM and FDA standards. There is no mention of an adjudication process by multiple experts for disputes in results.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices involving human interpretation, not for examination gloves whose performance is assessed through physical and chemical tests.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

Not applicable. This is a medical device (examination glove), not an algorithm or AI system. Its performance is inherent to the product's physical and chemical properties as measured by standardized tests.

7. The Type of Ground Truth Used:

The ground truth used is based on established industry standards and regulatory requirements. Specifically, it relies on:

ASTM D6319-00aE3 Standard: This standard specifies requirements for medical gloves for single use.
FDA 1000 ml watertight test: This is a regulatory requirement for acceptable barrier integrity.
Biocompatibility Tests: Primary Dermal Irritation Test and Guinea Pig Sensitization (Buehler) test, which determine the biological safety of the gloves.
FDA minimum powder residual content: A regulatory requirement for powder-free gloves.

8. The Sample Size for the Training Set:

Not applicable. There is no "training set" in the context of physical medical device testing for examination gloves. The manufacturing process is controlled, and the product is tested against predefined specifications.

9. How the Ground Truth for the Training Set Was Established:

Not applicable, as there is no training set for this type of device and study.

Summary

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KOH2101

SEAL POLYMER INDUSTRIES BERHAD Lot 72706, Jalan Lahat Kawasan Perindustrian Bukit Merah 31500 Lahat, Perak Tel : 605 - 322 3200, Fax : 605 - 322 2300

SMDA 510 (K) SUMMARY 1.0 SEAL POLYMER INDUSTRIES BERHAD 2.0 Submitter Lot 72706, Jalan Lahat Kawasan Perindustrian Bukit Merah 31500 Lahat, Perak, Malaysia (60 5) 322 3200 Tel (60 5) 322 2300 Fax Ms. CHUN CHOOl FONG Name of Contact Person Date of Summary Prepared August 2, 2004 Name of Device 3.0 Powder Free Nitrile Examination Gloves Device Name Exam Glove Common Name Nitrile Patient Examination Glove Classification Name

Identification of the Legally Marketed Devices 4.0

Class 1 Nitrile Patient Examination Glove 80LZA, powder free that meets all the requirements of ASTM Standard D6319-00a53 and FDA requirements.

Description of The Device 5.0

Class 1 Nitrile Patient Examination Glove 80LZA, powder free that meets all the Cluss T Thirne Fullions Channing of 20-00a53 and FDA Water Leak Test.

6.0 The Intended Use of Glove

A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hands or finger to prevent contamination between patient and examiner.

Page 1 of 3 ATTACHMENT O

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SEAL POLYMER INDUSTRIES BERHAD

Lot 72706, Jalan Lahat Kawasan Perindustrian Bukit Merah 31500 Lahat, Perak Tel : 605 - 322 3200, Fax : 605 - 322 2300

Summary of Performance Data: 7.

Performance data of gloves based on ASTM D6319-00a53 and FDA 1000 ml watertight test.

TEST	ASTM D6319-00aE3AQL=2.5%	POWDER FREE NITRILE EXAMGLOVESAQL=2.5%
1. Watertight (1000 ml)	G I	Pass G I
2. Length (mm)Size	Min 230
XS	Min 230	240 mm minimum forall sizes
S	Min 230
M	Min 230
L	Min 230
XL	Min 230
3. Palm width (mm)Size	-
XS	-	<80 mm
S	$80 +/- 10$	$85 +/- 3$ mm
M	$95 +/- 10$	$95 +/- 3$ mm
L	$111 +/- 10$	$105 +/- 3$ mm
XL	-	$111 +/- 3$ mm
XXL	-	$120 +/- 3$ mm
4. Thickness (mm)(Single Layer)
Finger	Min 0.05	0.08 minimum
Palm	Min 0.05	0.08 minimum
5. Physical Properties
Before AgingTensile Strength (Mpa)	Min 14.0	20.7*
Ultimate Elongation (%)	Min 500	609*
After AgingTensile Strength (Mpa)	Min 14.0	22.9*
Ultimate Elongation (%)	Min 400	597*
6. Powder Content	-	Below 2mg / glove

The average number obtain from Attachment C.

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SEAL POLYMER INDUSTRIES BERHAD

Lot 72706, Jalan Lahat Kawasan Perindustrian Bukit Merah 31500 Lahat, Perak Tel : 605 - 322 3200, Fax : 605 -- 322 2300

The performance data of the glove as showed above meet the ASTM D6319-00a53 8. Standard and FDA's requirement. Standard and I BA 9 row 2mg per glove, which meet the FDA Requirements.
The Biocompatibility Test consists of Primary Dermal Irritation Test and Guinea 9. Pig Sensitization (Buehler) test. The gloves pass the Biocompatibility Tests.
Conclusion 10.

We concluded that the Powder Free Nitrile Examination Gloves meet the below specifications:

ASTM D6319-00a53 Standard -
FDA pinhole requirements ﺘ
FDA minimum powder residual content ﻴﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟ

Page 3 of 3 ATTACHMENT O

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image is a black and white circular seal. The seal contains the logo for the U.S. Department of Health and Human Services. The logo is a stylized image of an eagle with three lines representing its wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged around the perimeter of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 2 7 2004

Ms. Chun Chooi Fong Quality Management System Manager Seal Polymer Industries Berhad Lot 72706, Jalan Lahat, Kawasan Perindustrian Bukit Merah, 31500 Lahat, Perak, MALAYSIA

Re: K042101

K042101
Trade/Device Name: Cashmere Powder Free Nitrile Examination Gloves Green Regulation Number: 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LZA Dated: August 2, 2004 Received: August 4, 2004

Dear Ms. Fong:

We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your Section 910(t) profit is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in indications for use stated in the choiosaro, to tegan.
interstate commerce prior to May 28, 1976, the enactment date of the Medical Device interstate conments, or to tvay 20, 1978, and saiffed in accordance with the provisions of Amendments, of to devices that have boom require approval of a prematical the premarket the Federal Food, Drug, and Cosmetic Pro (110) ------------------------------------------------------------------------------------------------------------------------------approval application (1 Nirf). Fou frols provisions of the Act include controls provisions of the Act. The gentiral of devices, good manufacturing practice, requirements for unitual reagainst misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III If your device is classified (sec above) into controls. Existing major regulations affecting (PMA), it may be subject to such additional controllations, Title 21, Parts 800 to 898. In the Foderal your device can be found in the Code of Peacharters on the Federal Register.

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Page 2 - Ms. Fong

Please be advised that FDA's issuance of a substantial equivalence determination does not Please be advised that PDA s Issualics of a substance complies with other requirements
mean that FDA has made a determination that your devices with other Federal agencies mean that FDA has made a decemination administered by other Federal agencies.
of the Act or any Federal statutes and regulations and not limited to: registration of the Act or any rederal statutes and registerents, including, but not limited to: registration
You must comply with all the Act's requirements, including and memorical You must comply with an the Act 3 requirements and 801); good manufacturing practice
and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing (21 CFR Par and listing (21 CFR Part 807), labelling (21 CFR Parter (21 CFR Part 820); and if
requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if requirements as set forth in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k)
the success of the county of the country of would as a f This letter will allow you to begin matically your as a lovivalence of your device to a premarket notification. The PDA intellige of substance of Submitter on the vice and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), If you desire specific advice for your device on our see at (31) 594-4618. Also, please note the regulation please contact the Office of Comphanes are (2011) - 1 CFR Part 807.97). You
entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). You entitled, "Misoranding by reference to premained on your responsibilities under the tall from the may obtain offer general miormation on Jour Paper Assistance at its toll-free Division of Sinan Manufactacles, 2019, 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Chiu Lin, Ph.D.

Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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INDICATIONS FOR USE STATEMENT

: Seal Polymer Industries Berhad Applicant

510(K) Number :

Device Name : Powder Free Nitrile Examination Gloves

Green

Indication For Use:

A patient examination glove is a disposable device intended for medical purposes that is worn
er. A patient examination glove is a disposable device michod for meetime paper.
on the examiner's hands or finger to prevent contamination between patient and examiner.

Prescription Use (Part 21 CFR 801 Subpart D)

(

AND/OR

Over-The-Counter Use _ (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Kein Muling
(Division Sign-Off)

Division of Anesthesiology, General Hospital, Infection Control, Dental Devices

510(k) Number: K 042101

Page 1 of ____________________________________________________________________________________________________________________________________________________________________

Regulation Number and Section

§ 880.6250 Non-powdered patient examination glove.

(a)
Identification. A non-powdered patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. A non-powdered patient examination glove does not incorporate powder for purposes other than manufacturing. The final finished glove includes only residual powder from manufacturing.(b)
Classification. Class I (general controls). The device, when it is a finger cot, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.